The present disclosure relates to an apparatus and method for performing a cecostomy.
A cecostomy is the placement of a catheter into the cecum of a patient. The cecum is part of the large intestines and located immediately after the small intestine. Patients with fecal incontinence can use a cecostomy tube to administer an enema to quickly and completely evacuate the large intestines from the upper portion of the large intestine to the rectum. This method of delivering an enema (antegrade) is more effective than a retrograde enema since administration of a retrograde enema often involves substantial leakage. A cecostomy clearly improves the quality of life for those suffering chronic fecal incontinence.
Fecal incontinence can be associated with disorders of peristalsis, sensation, sphincter control, anatomy or psychosocial issues. Among the many is etiologies are myelomeningocele, cloacal anomalies, caudal regression syndrome, paraplegia, paralysis, cerebral palsy, and disorders of intestinal motility. Traditional treatments include dietary modification, laxatives, suppositories, enemas, manual dis-impaction, biofeedback and electro-stimulation. Despite these efforts, many patients do not achieve fecal continence and continue to have bowel accidents. Severe fecal incontinence, particularly among children, can result in severe constipation and leakage of fluid from the anus, a source of embarrassment for the child.
A surgically created cecostomy carries risks of stomal stenosis (10 to 33 percent), stomal leakage, appendiceal necrosis, general anesthesia and bowel perforation, but has been found to be an appropriate solution for many patients.
The current method of performing a cecostomy is a two-step process. The procedure requires the inflation of the colon with air until the cecum is distended. A small needle is inserted through the skin into the cecum, and then the surgeon attaches the cecum to the abdominal wall with stitches. A catheter is then threaded into the cecum in place of the needle. To confirm proper placement of the catheter, contrast dye is usually injected through the catheter, using fluoroscopy to make sure the dye travels into the cecum. This initial cecostomy is allowed to heal for about 6 weeks in order to form a stable stoma. Once it is determined that the stoma has healed properly, the initial placement is followed with the placement of a final cecostomy catheter.
One final prior art cecostomy catheter, as shown in FIG. 1, has a low profile “trapdoor” flange fitting 2, designed to lay flat against the skin when not in use, for enhanced patient compliance. This device is described in detail in U.S. Pat. No. 6,223,070 to Dr. Peter Chait. Dr. Chait's device does not use a separate retention element but has helical coils 4 that re-form within the intestinal cavity upon the removal of a stiffener (not shown) that is used to insert it. The coils 4 serve as a retaining mechanism that hold the trapdoor flange 2 against the skin 6 of the patient and keep the catheter from simply falling out of the stoma. Since is there are a plurality of coils, it can adjust to varying distances from the skin 6 to the internal intestinal cavity 8.
The Chait Trapdoor™ Cecostomy Catheter is percutaneously inserted through an existing mature tract, created as described above. Once the initial catheter is removed (over a guide wire) a metal stiffener is inserted into the Chait Trapdoor™ Cecostomy Catheter to straighten the coils and to assist in pushing the catheter through the tract over the pre-positioned guide wire. Once the cecostomy catheter is inserted, the stiffener is removed until the Trapdoor™ flange is flush with the skin at the access site. When the stiffener and guide wire are removed, the extra catheter coils will re-form within the cecum, holding the cecostomy catheter in place.
While the prior art procedure has helped many patients struggling with fecal incontinence to lead more normal lives, the requirement for two separate surgeries creates two potential incidents of infection and other complications. In addition, the helical coils can become plugged after some time and so the cecostomy catheter must be replaced from time to time. Lastly, the Chait catheter can sometimes leak when the catheter is not in use.
What is needed is a device for the administration of an antegrade enema that may be inserted into the cecum in a single step, not requiring a primary and secondary surgical operation. This device should also be simple to operate and effectively allow the patient to control the conditions surrounding the administration of an enema. The device should not need to be replaced on a regular basis because of clogging and should minimize leakage outside of the body when not in use.